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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP

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ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP Back to Search Results
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The pump has not been returned to animas. If the device is returned, an evaluation shall be completed and a supplemental report will be filed. No conclusions can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a power (intermittent power) issue. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Follow-up #1: date of submission 05/26/2016. Device evaluation: the device has been returned and evaluated by product analysis on 05/12/2016 with the following findings: the review of the black box showed multiple unexpected power reboots. The battery compartment was undamaged and the returned battery cap was able secure and maintain the electrical connection. The battery cap contact height and width measured within specifications. Additionally, the battery cap was fastened and then unscrewed half turn with no power reboot occurrences. The ez-prime steps were performed correctly with no power interruptions, errors, alarms or warnings. Upon removal of the pump cover, no intermittent condition was found to the power circuit or to the continuous glucose monitoring module.
 
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Brand NameANIMAS VIBE
Type of DeviceINSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer (Section G)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer Contact
karin sargrad
200 lawrence dr
west chester, PA 19380-3428
4843561808
MDR Report Key5583978
MDR Text Key43547188
Report Number2531779-2016-07995
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 04/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610007521337098116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age10 MO
Event Location No Information
Date Manufacturer Received04/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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